Morning Briefing
Summaries of health policy coverage from major news organizations
Manufacturing Hiccup Spells Trouble For New Obesity Medicine Wegovy
FiercePharma: Novo Nordisk's Weight Loss Drug Wegovy To Run Short Amid Contract Manufacturer Hiccup
Demand for Novo Nordisk’s obesity medicine Wegovy is high, but a manufacturing hitch with one of the Danish company’s partners has put near-term supply in jeopardy. Novo Nordisk on Friday said that a contract manufacturer in charge of syringe filling for Wegovy pens in the U.S. had temporarily halted deliveries following issues with good manufacturing practices. (Kansteiner, 12/20)
In other pharmaceutical news —
Stat: A New ‘Biological Computer' Targets Cancer While Sparing Healthy Cells
The holy grail of cancer drug targets is akin to a unicorn horn: a marker that only cancer cells have, clearly distinguishing them from healthy cells. In reality, nearly all cancer drug targets are also found on many healthy cells, leading to serious off-tumor toxicity that — in extreme scenarios — can be fatal. Synthetic biologist Kobi Benenson might have a way around that. Inside an engineered virus, he and his colleagues at ETH Zurich packaged a programmable genetic circuit that uses multiple targets to build a profile of a cancer cell. Detailed in a mouse study recently published in Science, it’s a nanoscopic biological computer that roams through the body, executing a program that seeks to recognize and kill cells matching that cancer profile, but spares healthy cells that don’t fit all the criteria. (Chen, 12/22)
Reuters: U.S. FDA Puts Plans To Test LSD In Anxiety Patients In Clinical Study On Hold
The U.S. Food and Drug Administration put a clinical hold on Mind Medicine Inc's application to start testing the psychedelic drug commonly known as LSD in patients with generalized anxiety disorder. The Canada-based drug developer said on Tuesday the FDA hold was related to its investigational new drug application, which is required to start a mid-stage trial of the drug -- lysergic acid diethylamide. (12/21)
FiercePharma: Otezla Now The Only Oral Drug For All Levels Of Plaque Psoriasis
As Amgen’s Otezla girds for competition against a potentially formidable rival, the company is doing all it can to gain an edge for the plaque psoriasis treatment. On Monday, Otezla nabbed an FDA approval that expands its use to those who are candidates for phototherapy or systemic therapy. The indication, for the milder version of the disorder, now makes Otezla the only oral treatment sanctioned all severities of plaque psoriasis—mild, moderate and severe. It also brings roughly 1.5 million potential patients into the fold. (Dunleavy, 12/21)
FiercePharma: 2022 Forecast: Cell, Gene Therapy Makers Push Past Regulatory, Payer Hurdles To Set Up High Hopes For 2022
For developers of cell and gene therapies, the path to market often seems to be marred with potholes. The FDA rejected BioMarin Pharmaceutical’s gene therapy to treat hemophilia A in 2020, citing the need for more durability data and sending the company’s shares down more than 20% in a day. In November of this year, the FDA delayed a much-anticipated decision on multiple myeloma CAR-T candidate cilta-cel from Legend Biotech and Johnson & Johnson, causing Legend’s stock to fall nearly 8%.Now, those companies are preparing for the FDA to finally hand down its rulings—and they’re making those preparations optimistically. (Weintraub, 12/22)
On drug costs —
Columbus Dispatch: PBM Fees That Affect Drug Costs For Consumers, Taxpayers Under Review
In a surprise move, a top federal regulator promises to delve into extensive fees assessed on pharmacies by drug-chain middlemen in what could be the first nation-wide crackdown on pharmacy benefit managers. At stake are billions of dollars in prescription drug costs born by consumers and taxpayers. The probe by the Centers for Medicare and Medicaid Services (CMS) will center on huge increases in direct and indirect remuneration fees that PBMs charge pharmacies on Medicare prescriptions. These DIR fees were implemented as a way to incentivize U.S. pharmacies collecting millions of Medicare dollars to do more than simply push pills. (Rowland, 12/17)
KWTX: With Proposals To Cap Drug Costs Stalled, Clinics Say Help Still Needed
As President Joe Biden says his hopes for the Build Back Better program are stalled, so is the hope to cap some drug prices. That is one of the provisions with the proposal. It is something those who work around health care say there is a need for. There are a lot of people in the Central Texas area who need help paying for drug costs, particularly when it comes to things like insulin. “When we saw the pandemic happen it just amazed us how many patients, how many individuals who really needed health care services,” said Taneika Moultrie, executive director of the Greater Killeen Community Clinic. (Cantu, 12/17)
CNBC: You Can Appeal Those Income-Related Medicare Charges. Here's How
For some Medicare beneficiaries, premiums are only the start of what they must pay monthly for coverage. That is, instead of paying the standard premiums for Part B (outpatient care) and Part D (prescription drugs) like most Medicare enrollees, their income is high enough for “income-related monthly adjustment amounts,” or IRMAAs, to kick in. However, the surcharge is typically based on their tax return from two years earlier — which may not accurately reflect their current financial situation. (O'Brien, 12/16)
